Use of PRP in Endometrial Reconstruction

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ClinicalTrials.gov Identifier: NCT03249415

Recruitment Status : Recruiting

First Posted : August 15, 2017

Last Update Posted : February 2, 2021

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Sponsor:

Information provided by (Responsible Party):

Fundación IVI

Study Description

Brief Summary:

Infertility, which affected 48.5 million couples worldwide in 2010 alone, has many causes; some causes result from issues related to the endometrium. Unfortunately, no cure exists for medical conditions resulting in the destruction of the endometrium, or for non-functional uterus. Thus, safe and effective therapies are needed to treat these diseases and to establish fertility in affected women. These novel techniques refer to the use and application of regenerative/paracrine factors to regenerate the endometrium in patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA).These new therapies based on the injection of the identified regenerative/paracrine factors and the platelet-rich plasma (PRP) from whole blood in an immunodeficient mouse model with AS/EA, evaluating their contribution and/or effect in the endometrial repair by functional proofs.

Condition or disease
Asherman Syndrome Endometrial Atrophy

Detailed Description:

The objective is to know the effect of these regenerative factors obtained from Platelet-Rich Plasma in an immunodeficient murine model with AS/EA Blood from patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA) will be collected, maintained under anticoagulant solution and after several centrifugations PRP will be obtained. Demonstration of a functional endometrium will be proved determining pregnancy and implantation rates as well as the number of live pups/pregnant female in our mice model. Also, the uterus histology will be analysed in treated and untreated mice

Study Design

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Study Type :	Observational
Estimated Enrollment :	10 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Endometrial Reconstruction by Human Regenerative Factors Derived From Platelet-Rich Plasma in Mice Models
Actual Study Start Date :	July 18, 2017
Estimated Primary Completion Date :	December 2021
Estimated Study Completion Date :	December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Plastic and Cosmetic Surgery

Genetic and Rare Diseases Information Center resources: Asherman's Syndrome

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Endometrial thickness after reconstruction in murine model [ Time Frame: through study completion, an average of 1 year ]
Using histological and functional technologies demonstration of regeneration ability of PRP

Biospecimen Retention: Samples Without DNA

Platelet-Rich Plasma from Whole Blood.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	25 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Participant with endometrial pathologies.
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.

Criteria

Inclusion Criteria:

Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.
No pregnancy after hormonal treatment.

Exclusion Criteria:

Psychiatric diseases.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249415

Contacts

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Contact: Irene Cervello, PhD	0034963903305	Irene.Cervello@ivi.es

Locations

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Spain
IVI Barcelona	Recruiting
Barcelona, Spain
Contact: Irene Cervelló

Sponsors and Collaborators

Fundación IVI

Investigators

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Principal Investigator:	Irene Cervello, PhD	Fundación IVI

More Information

Publications of Results:

Cervelló I, Gil-Sanchis C, Santamaría X, Cabanillas S, Díaz A, Faus A, Pellicer A, Simón C. Human CD133(+) bone marrow-derived stem cells promote endometrial proliferation in a murine model of Asherman syndrome. Fertil Steril. 2015 Dec;104(6):1552-60.e1-3. doi: 10.1016/j.fertnstert.2015.08.032. Epub 2015 Sep 15.

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Responsible Party:	Fundación IVI
ClinicalTrials.gov Identifier:	NCT03249415
Other Study ID Numbers:	1701-FIVI-003-IC
First Posted:	August 15, 2017 Key Record Dates
Last Update Posted:	February 2, 2021
Last Verified:	May 2020

Keywords provided by Fundación IVI:


Platelet-Rich Plasma Cell therapy Regenerative factors Autologous treatment Paracrine factors

Additional relevant MeSH terms:

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Gynatresia Atrophy Pathological Conditions, Anatomical

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